Quality Control Scientist II

Position Summary.

The Quality Control (QC) Scientist II will support the development of, and maintain, key elements of the Nuclein quality management system. This role will provide support for QC activities related to incoming, component and finished product release and development of the Nuclein QC laboratory. In collaboration with Assay Development, Operations, and Engineering colleagues, the QC Scientist II will ensure that Nuclein products meet the highest standards of quality and are compliant with all applicable regulations.

Essential Duties and Responsibilities. 

·         Executes QC testing and inspection of materials for release to production and finished product testing, including record review for compliance

·         Authors, reviews, and executes QC test methods and procedures as a subject matter expert

·         Develops and reviews test method validation/verification protocols and reports

·         Supports the development and maintenance of QC laboratory, including authoring of Standard Operating Procedures (SOPs) for QC lab personnel

·         Supports day-to-day QC lab operations, including ordering/receiving supplies and operating/maintaining laboratory equipment

·         Supports investigations into deviations, non-conformances, and CAPAs, including authoring and approval of investigation records

·         Mentors QC Technicians

·         Ensures compliance to 21 CFR Part 820, ISO 13485, and other applicable regulations by providing support through interpretation of regulations and leading improvement initiative

·         Supports internal and external inspections/audits

        ·         Performs other duties and responsibilities as assigned by management, including leading cross-functional tasks                

Education, Qualifications, and/or Experience. 

·         Bachelor’s degree in a Science, such as Molecular Biology, Chemistry, Biomedical Sciences or related technical field

·         At least 5 years of experience in a laboratory setting, preferably within a medical device ISO 13485 environment, or similar FDA regulated industry

·         Experience working with IVDs preferred (PCR technology/platform a plus)

·         Hands-on experience in DNA, RNA, PCR and general molecular biology laboratory techniques preferred

·         Ability to properly operate laboratory tools and equipment including pipettes, centrifuges, vortex mixers, incubators, PCR enclosures, biosafety cabinet, refrigerators and freezers

·         Familiar with statistical techniques for determine QC criteria and sample size

·         Ability to perform repetitive testing with a high level of attention to detail

·         Have excellent written and verbal communication skills – able to train others in quality principles and operations

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: < 25 lbs

·         Position: Standing and sitting

·         Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

        Local candidates only. Sponsorship is not being offered at this time. No recruiters or agencies, please.